Multi-arm Optimization of Stroke Thrombolysis



Status:Not yet recruiting
Conditions:Peripheral Vascular Disease, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - Any
Updated:3/10/2019
Start Date:June 2019
End Date:April 2023
Contact:Opeolu Adeoye, MD
Email:adeoyeo@ucmail.uc.edu
Phone:513-558-3117

Use our guide to learn which trials are right for you!

Multi-arm Optimization of Stroke Thrombolysis (MOST): a Blinded, Randomized Controlled Adaptive, Multi-arm, Adjunctive-thrombolysis Efficacy Trial in Ischemic Stroke

The primary efficacy objective of the MOST trial is to determine if argatroban (100µg/kg
bolus followed by 3µg/kg per minute for 12 hours) or eptifibatide (135µg/kg bolus followed by
0.75µg/kg/min infusion for two hours) results in improved 90-day modified Rankin scores (mRS)
as compared with placebo in acute ischemic stroke (AIS) patients treated with 0.9mg/kg IV
rt-PA within three hours of symptom onset. Patients may also receive endovascular
thrombectomy (ET) per usual care. Time of onset is defined as the last time the patient was
last known to be well.


Inclusion Criteria:

1. Acute ischemic stroke patients

2. Treated with 0.9mg/kg IV rt-PA within 3 hours of stroke onset or time last known well

3. Age ≥ 18

4. NIHSS score ≥ 6 prior to IV rt-PA

5. Able to receive assigned study drug within 60 minutes of initiation of IV rt-PA

Exclusion Criteria:

1. Known allergy or hypersensitivity to argatroban or eptifibatide

2. Previous stroke in the past 90 days

3. Previous intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arterial
venous malformation

4. Clinical presentation suggested a subarachnoid hemorrhage, even if initial CT scan was
normal

5. Surgery or biopsy of parenchymal organ in the past 30 days

6. Trauma with internal injuries or ulcerative wounds in the past 30 days

7. Severe head trauma in the past 90 days

8. Systolic blood pressure >180mmHg post-IV rt-PA

9. Diastolic blood pressure >105mmHg post-IV rt-PA

10. Serious systemic hemorrhage in the past 30 days

11. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or
oral anticoagulant therapy with INR >1.5

12. Positive urine pregnancy test for women of child bearing potential

13. Glucose <50 or >400 mg/dl

14. Platelets <100,000/mm3

15. Hematocrit <25 %

16. Elevated PTT above laboratory upper limit of normal

17. Creatinine > 4 mg/dl

18. Ongoing renal dialysis, regardless of creatinine

19. Received Low Molecular Weight heparins (such as Dalteparin, Enoxaparin, Tinzaparin) in
full dose within the previous 24 hours

20. Abnormal PTT within 48 hours prior to randomization after receiving heparin or a
direct thrombin inhibitor (such as bivalirudin, argatroban, dabigatran or lepirudin)

21. Received Factor Xa inhibitors (such as Fondaparinaux, apixaban or rivaroxaban) within
the past 48 hours

22. Received glycoprotein IIb/IIIa inhibitors within the past 14 days

23. Pre-existing neurological or psychiatric disease which confounded the neurological or
functional evaluations e.g., baseline modified Rankin score >3

24. Other serious, advanced, or terminal illness or any other condition that the
investigator felt would pose a significant hazard to the patient if rt-PA,
eptifibatide or argatroban therapy was initiated

a. Example: known cirrhosis or clinically significant hepatic disease

25. Current participation in another research drug treatment protocol - Subjects could not
start another experimental agent until after 90 days

26. Informed consent from the patient or the legally authorized representative was not or
could not be obtained

27. High density lesion consistent with hemorrhage of any degree

28. Large (more than 1/3 of the middle cerebral artery) regions of clear hypodensity on
the baseline CT Scan. Sulcal effacement and/or loss of grey-white differentiation
alone are not contraindications for treatment
We found this trial at
50
sites
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
1500 Northwest 12th Avenue # 106
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
?
mi
from
Providence, RI
Click here to add this to my saved trials
1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
?
mi
from
Abington, PA
Click here to add this to my saved trials
Albuquerque, New Mexico 87106
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Ann Arbor, Michigan 48109
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Austin, Texas 78701
?
mi
from
Austin, TX
Click here to add this to my saved trials
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials
Bethlehem, Pennsylvania 18015
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45211
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45220
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45236
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45242
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45255
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
?
mi
from
Dayton, OH
Click here to add this to my saved trials
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
1 Medical Village Drive
Edgewood, Kentucky 41017
?
mi
from
Edgewood, KY
Click here to add this to my saved trials
501 E. Hampden Ave.
Englewood, Colorado 80113
303-788-5000
?
mi
from
Englewood, CO
Click here to add this to my saved trials
4900 Houston Road
Florence, Kentucky 41042
?
mi
from
Florence, KY
Click here to add this to my saved trials
85 North Grand Avenue
Fort Thomas, Kentucky 41075
?
mi
from
Fort Thomas, KY
Click here to add this to my saved trials
Grand Rapids, Michigan 49503
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Greenville, South Carolina 29615
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Kansas City, Missouri 64111
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
9300 Campus Point Drive
La Jolla, California 92037
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
?
mi
from
Madison, WI
Click here to add this to my saved trials
8900 N Kendall Dr
Miami, Florida 33176
(786) 596-1960
Baptist Hospital of Miami Since 1960, Baptist Hospital of Miami has been one of the...
?
mi
from
Miami, FL
Click here to add this to my saved trials
Morgantown, West Virginia 26506
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New York, New York 10032
?
mi
from
New York, NY
Click here to add this to my saved trials
350 W Thomas Rd
Phoenix, Arizona 85013
(602) 406-3000
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15219
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
3635 Vista Avenue
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
640 Jackson Street
Saint Paul, Minnesota 55101
651-254-3456
Regions Hospital Established in 1872, Regions Hospital is a private, not-for-profit organization. The hospital provides...
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
333 Smith Ave
Saint Paul, Minnesota 55102
(651) 241-8000
United Hospital United Hospital is the largest hospital in the Twin Cities east metro area,...
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
50 North Medical Drive
Salt Lake City, Utah 84132
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
200 West Arbor Drive
San Diego, California 92103
?
mi
from
San Diego, CA
Click here to add this to my saved trials
300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
?
mi
from
Stanford, CA
Click here to add this to my saved trials
Syracuse, New York 13210
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
Whittier, California 90602
?
mi
from
Whittier, CA
Click here to add this to my saved trials
York, Pennsylvania 17403
?
mi
from
York, PA
Click here to add this to my saved trials